Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364143
• Other study ID #: IHL-PRT001
• Status: Completed
• Phase: Phase 1
• Start date: September 2006
• Est. completion date: June 2011

Study information

• Verified date: July 2019
• Source: Yakult Honsha Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is safe and effective in the treatment of advanced solid tumors.

Description:

This is a Phase I dose-escalation study of intravenous administration of IHL-305 in patients with advanced solid tumors. Patients will receive IHL-305 as an intravenous infusion over 60 minutes on Day 1 followed by a 27-day observation period for a total of 28 days (4 weeks) per cycle. Two patient populations will be evaluated separately; patients with UGT1A1*28 genotype homozygous wild-type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed malignant solid tumor and not a candidate for known regimens or protocol treatments of higher efficacy or priority

2. Failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist

3. Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)

4. ECOG performance status of 0, 1, or 2

5. 18 years of age or older

6. Normal organ and bone marrow function as defined by:

• absolute neutrophil count greater than or equal to 1,500 cells/microliter

• platelets greater than or equal to 100,000 cells/microliter

• total bilirubin within normal institutional limits

• AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal (ULN) or less than or equal to 5.0 x ULN in patients with liver metastases

• plasma creatinine less than or equal to 1.5 x institutional ULN OR

• creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Previously treated with irinotecan, or had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or not recovered from adverse effects due to agents administered more than 4 weeks earlier

2. Receiving any other investigational agent

3. Known brain metastases

4. History of allergic reactions attributed to compounds of similar chemical composition to IHL-305

5. Concurrent serious infections (i.e., requiring an intravenous antibiotic)

6. Pregnant women or women of childbearing potential and not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential; no breast-feeding while on study.

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

8. Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; history of myocardial infarction within one year of study entry; uncontrolled dysrhythmias; or poorly controlled angina.

9. History of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF], greater than or equal to 3 beats in a row); QTc greater than or equal to 450 msec for men and 470 msec for women; or left ventricular ejection fraction (LVEF) less than or equal to 40% by multi-gated acquisition scan (MUGA).

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• IHL-305 (irinotecan liposome injection)

Locations

Country	Name	City	State
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Yakult Honsha Co., LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity within 28 days of treatment administration for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
Primary	determination of maximum tolerated dose (MTD) and recommended Phase 2 dose for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
Secondary	Tumor shrinkage per Response Evaluation Criteria in Solid Tumors (RECIST) every 8 weeks/2 cycles while receiving study drug for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
Secondary	limited pharmacokinetics (PK) for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
Secondary	limited incidence and severity of adverse events (AEs) and PK for UGT1A1 homozygous (*28/*28) patients